A group of Democratic senators ask HHS Office of Inspector General to clarify how it will oversee direct-to-consumer prescription drug sales tied to t...
FDA releases a corrected version of a 12/30 Complete Response Letter issued to Corcept Therapeutics, indicating that the agency had repeatedly warned ...
Ultragenyx Pharmaceutical resubmits a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilippo syndrome Type A...
Elevar Therapeutics files an NDA for lirafugratinib as a second-line treatment for patients with cholangiocarcinoma whose tumors harbor FGFR2 fusions ...
Sen. Rick Scott (R-FL) introduces legislation that would require prescription drug labels in the U.S. to disclose where drugs and their active pharmac...
FDA approves Tenpoint Therapeutics Yuvezzi as the only combination eye drop approved to treat presbyopia in adults.
FDA posts an updated guidance clarifying when clinical decision support software functions fall outside the definition of a regulated medical device.
An industry consultant says reduced FDA staffing levels and high turnover are extending regulatory timelines and forcing drug developers to invest mor...